BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT, CRYSTALENS, DELIVERY SYSTEM

    MDR report key: 1940347 · Received December 20, 2010

    Report

    Report Number
    2031924-2010-00232
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A CRYSTALENS USING THE CI-28 DELIVERY DEVICE. DURING INSERTION, THE SURGEON OBSERVED THAT THE HAPTIC CAUGHT THE CORNER OF THE CAPSULE AND THE CAPSULE WAS TORN. THERE WAS LOSS OF VITREOUS. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. AN ANTERIOR VITRECTOMY WAS PERFORMED. AN ANTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY. SUTURES WERE APPLIED TO CLOSE THE WOUND. ACCORDING TO THE PHYSICIAN, THE PATIENT'S CURRENT PROGNOSIS IS GOOD. REFERENCE MDR 2031924-2010-00231.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALSERT, CRYSTALENS, DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH & LOMB CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CRYSTALENS IOL (B&L)